Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
Public ClinicalTrials.gov record NCT00427895. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Active-controlled, Modified Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) Compared To A 23-valent Pneumococcal Polysaccharide Vaccine (23vps) In Adults 60 To 64 Years Old Who Are Naive To 23vps And The Safety, Tolerability, And Immunogenicity Of 13vpnc In Adults 18-59 Years Old Who Are Naïve To 23vps
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.
Study identification
- NCT ID
- NCT00427895
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,141 participants
Conditions and interventions
Conditions
Interventions
- 13-valent pneumococcal conjugate vaccine (13vPnC) Biological
- 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 27, 2007 (Actual)
- Primary completion
- Aug 1, 2011 (Actual)
- Completion
- Aug 1, 2011 (Actual)
- Last update posted
- Nov 15, 2021
2007 – 2011
United States locations
- U.S. sites
- 26
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Accelovance | Huntsville | Alabama | 35802 | — |
| East Valley Family Physicians, PLC | Chandler | Arizona | 85224 | — |
| Clinical Research Advantage/Central Phoenix | Phoenix | Arizona | 85020 | — |
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | — |
| Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| Accelovance | South Bend | Indiana | 46601 | — |
| Heartland Research Associates LLC | Wichita | Kansas | 67205 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | — |
| Kentucky Pediatric /Adult Research | Bardstown | Kentucky | 40004 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| Radiant Research - St. Louis | St Louis | Missouri | 63141 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| PMG Research of Raleigh, LLC | Cary | North Carolina | 275188 | — |
| PMG Research of Raleigh, LLC | Raleigh | North Carolina | 27609 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Primary Physicians Research | Pittsburgh | Pennsylvania | 15205 | — |
| Primary Physicians Research | Upper Saint Clair | Pennsylvania | 15241 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Internal Medicine and Pediatrics Associates of Bristol, PC | Bristol | Tennessee | 37520 | — |
| PMG Research of Bristoll, LLC | Bristol | Tennessee | 37620 | — |
| J. Lewis Research Inc./Foothill Family Clinic South | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research Inc./Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| J. Lewis Research/First Med | West Jordan | Utah | 84088 | — |
| Group Health Research Institute | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00427895, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 15, 2021 · Synced Oct 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00427895 live on ClinicalTrials.gov.